Statins are indispensable for lowering blood cholesterol levels and are increasingly being used to manage cardiovascular disorders, a major cause of death and morbidity around the world [1]. However, many statins suffer from poor solubility and thus low bioavailability.
Different strategies have been reported to improve drug solubility and dissolution in order to achieve a suitable systemic drug concentration and a desired pharmacological effect. These strategies can be classified into physical, chemical and other miscellaneous modifications techniques [6]. Reduction in a drug's particle size by micronization and nanosuspension formation, crystalline change by polymorph and amorphous/crystallin modifications, drug dispersion in hydrophilic carriers (solid dispersions), solid solutions and cryogenic methods are examples of physical modifications [7-11]. Derivatization, salt formation and complexation are common types of chemical modifications [12,13]. Cosolvency, hydrotropes, addition of surfactants and solubilizers, and supercritical fluid technology are good examples of other modifications [14-16].
Mucoadhesive buccal films are pharmaceutical dosage forms that utilize a water-dissolving polymer that allows the prepared films to quickly hydrate, adhere and dissolve when placed in the buccal, palatal, gingival, lingual, sublingual or cheek mucosa of the buccal cavity [20,21]. They are promising drug delivery systems that release their drug content directly toward the buccal mucosa with subsequent drug absorption through the venous blood system that drains from the cheek. Accordingly, development of these films has the advantage of avoiding the hepatic first pass effect [22].
Due to the bioavailability problems with oral delivery of statins, alternative and effective drug delivery systems are needed.